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Completed

NCT Number: NCT02656186

Supplementation With Nutrients Modulating IGF-1 and Cytokines in Elderly People at Risk of Undernutrition

The purpose of this study was to determine the improvement in nutritional status, especially in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the circulating cytokine levels, after providing extra protein and energy contents to community-dwelling older adults at risk of undernutrition.

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Key information

Conditions

Undernutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

65 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Sixty of aged over 65 years, living independently in the community for elderly people, nondiabetic subjects with serum prealbumin of under 30 mg/dL and BMI under 25 kg/m2 were recruited. The subjects were followed for a 2-week pre-intervention period, followed by an intervention period, which they received 2 cartons of liquid oral nutritional supplementation daily for 2 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • voluntarily agree to participate and sign in informed consent form
  • aged 65 years or older
  • a serum prealbumin level≤30 mg/dL and a BMI<25 kg/m2

Exclusion criteria

  • inability to perform oral ingestion
  • known allergies to milk or eggs
  • an inability to communicate, such as those with Alzheimer's disease
  • malabsorption syndrome, a history of gastrectomy or enterectomy
  • diabetes, liver disease, renal disease, neurological disease, pancreatitis, malignancy, cardiovascular or cerebrovascular disease, metabolic syndrome
  • any other disease requiring treatment, medication or alcohol abuse
  • any condition that the investigator believes may put the subjects at under risk

Treatment and study plan

Pre-intervention

Dietary Supplement

First 2-weeks : keeping routine dietary habit

Liquid nutritional supplement

Dietary Supplement

Pre-intervention period was followed by an intervention period, during which consumed twice-daily 200 mL cartons of oral liquid nutritional supplementation (total 400 mL daily, containing 16 g protein, 12 g fat and 60 g carbohydrate and providing 400 kcal)

Primary outcomes

  1. Prealbumin (mg/dL)

    Time frame: at pre-treatment (week -2)

  2. Prealbumin (mg/dL)

    Time frame: at baseline (week 0)

  3. Prealbumin (mg/dL)

    Time frame: at post-treatment (week 2)

  4. Transferrin (mg/dL)

    Time frame: at pre-treatment (week -2)

  5. Transferrin (mg/dL)

    Time frame: at baseline (week 0)

  6. Transferrin (mg/dL)

    Time frame: at post-treatment (week 2)

Secondary outcomes

  1. Weight (kg)

    Time frame: 4 weeks

    3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)

  2. Body mass index (kg/m2)

    Time frame: 4 weeks

    3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)

  3. Serum albumin (g/dL)

    Time frame: 4 weeks

    3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)

  4. Insulin growth factor-1 (ng/mL)

    Time frame: 4 weeks

    3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)

  5. Osmolality (mOsm/kgH2O)

    Time frame: 4 weeks

    3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Supplementation With Nutrients Modulating IGF-1 Negatively Correlated With Changes in the Levels of Proinflammatory Cytokines in Community-dwelling Elderly People at Risk of Undernutrition

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2016
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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